Rotatable device and method for fixing tricuspid valve tissue

ABSTRACT

The present disclosure relates to repair devices, repair systems, and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve. The repair device includes a pair of proximal arms and a pair of corresponding opposing distal arms, with each proximal arm and corresponding opposite distal arm forming an arm pair. The arms are actuated so that leaflet tissue is grasped between the proximal and distal arms, with a first leaflet being grasped by a first arm pair and a second leaflet being grasped by a second arm pair. A suture line is anchored at the second leaflet. Then, the repair device is pivoted to grasp and suture a third tricuspid leaflet to tie the second and third leaflets together. The clip remains deployed to tie the first and third leaflets together.

This application is a divisional of U.S. patent application Ser. No.15/377,793, filed Dec. 13, 2016, the entire contents of which areincorporated by reference herein.

BACKGROUND

The tricuspid valve controls blood flow from the right atrium to theright ventricle of the heart, preventing blood from flowing backwardsfrom the right ventricle into the right atrium so that it is insteadforced through the pulmonary valve and into the pulmonary arteries fordelivery to the lungs. A properly functioning tricuspid valve opens andcloses to enable blood flow in one direction. However, in somecircumstances the tricuspid valve is unable to close properly, allowingblood to regurgitate back into the atrium. Such regurgitation can resultin shortness of breath, fatigue, heart arrhythmias, and even heartfailure.

Tricuspid valve regurgitation has several causes. Functional tricuspidvalve regurgitation (FTR) is characterized by structurally normaltricuspid valve leaflets that are nevertheless unable to properly coaptwith one another to close properly due to other structural deformationsof surrounding heart structures. Often, the right ventricle is dilatedas a result of pulmonary hypertension or an abnormal heart musclecondition (cardiomyopathy).

Other causes of tricuspid valve regurgitation are related to defects ofthe tricuspid valve leaflets, tricuspid valve annulus, or othertricuspid valve tissues. In some circumstances, tricuspid valveregurgitation is a result of infective endocarditis, blunt chest trauma,rheumatic fever, Marfan syndrome, carcinoid syndrome, or congenitaldefects to the structure of the heart. Tricuspid valve conditions arealso often associated with problems related to the left side of theheart, such as mitral valve regurgitation.

Tricuspid valve regurgitation is often treated by replacing thetricuspid valve with a replacement valve implant or by repairing thevalve through an interventional procedure. One method for repairing thetricuspid valve is through annuloplasty. Annuloplasty is accomplished bydelivering and implanting a ring or band in the annulus of the tricuspidvalve to attempt to return the annulus to a functioning shape. Intricuspid valve repair procedures, a surgeon attempts to reshape orreposition tricuspid valve leaflets so that they can better coapt withone another to sufficiently close the valve and prevent regurgitation.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one exemplary technology area where some embodimentsdescribed herein may be practiced.

BRIEF SUMMARY

Certain embodiments described herein are directed to devices and methodsfor repairing tissue, such as tissue of a malfunctioning cardiac valve,including a regurgitant tricuspid valve. Some embodiments are directedto methods for repairing tissue by positioning a repair device at atargeted location. The repair device includes a pair of distal arms anda pair of corresponding proximal arms disposed opposite the pair ofdistal arms, each proximal arm and corresponding opposite distal armforming an arm pair. The repair device is actuated to grasp leaflettissue of the targeted valve between the proximal and distal arms. Afirst arm pair grasps tissue at a first engagement point, and a secondarm pair grasps tissue at a second engagement point. Preferably, thefirst and second engagement points are located respectively on first andsecond adjacent leaflets of a tricuspid valve.

The leaflet tissue at the second engagement point is sutured. Forexample, one or more suture lines are passed through the leaflet tissueand are anchored at the second engagement point to prevent the one ormore suture lines from detaching or tearing away from the secondengagement point. In some embodiments, a suturing catheter is positionednear the second arm pair and engages with the second arm pair to enabledeployment of the one or more suture lines at the leaflet tissue graspedby the second arm pair.

After deploying the one or more suture lines at the second engagementpoint, the second arm pair is pivoted to a third engagement point (e.g.,the third tricuspid leaflet) while the first arm pair remains engaged atthe first engagement point (e.g., the first tricuspid leaflet). Thepivoting motion carries the one or more suture lines deployed at thesecond engagement point (e.g., the second tricuspid leaflet) to thethird engagement point. Tension in the one or more suture lines can thenbe adjusted to tie together the tissue of the second engagement pointand third engagement point to a desired degree. The repair deviceremains deployed across the first and third engagement points to tietogether the tissue of the first and third engagement points. The repairdevice can be adjusted to tie the grasped tissue together to a desireddegree.

In certain embodiments, at least a first arm pair of the repair deviceincludes a point element configured to engage against leaflet tissue tofunction as a pivot point allowing a second arm pair to rotate about thepivot point. In some embodiments, at least the second arm pair includesa set of through holes through which one or more suture lines arepassable to enable suturing of leaflet tissue grasped by the second armpair. In some embodiments, the second arm pair is independentlyadjustable so that the first arm pair can remain in a closed/graspedconfiguration during pivoting while the second arm pair is in a moreopen configuration to allow it to rotate around the first engagementpoint.

In some embodiments, a heart valve repair system includes a repairdevice and a suturing catheter. The suturing catheter includes aninternal lumen through which one or more suture lines are extendable,the suturing catheter being configured to engage with the second armpair of the repair device to enable passage of the one or more suturelines through the leaflet tissue grasped by the second arm pair.

In certain embodiments, a repair device includes a proximal member withan axial lumen and a plurality or extendable arms which may be extendedto an open position transverse to the axial lumen, and a distal memberdisposed at least partially within the axial lumen of the proximalmember so as to be axially translatable relative to the proximal member.The distal member includes an end section extending distally beyond theproximal member. The end section includes a plurality of extendable armswhich are extendable to an open position transverse to an axis of thedistal member.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 illustrates a human heart showing normal blood flow paths;

FIG. 2 illustrates a superior view of a normally functioning tricuspidvalve in a closed position;

FIG. 3 illustrates a superior view of a tricuspid valve in an openposition;

FIG. 4 illustrates a superior view of a malfunctioning tricuspid valveunable to properly close;

FIG. 5 illustrates an exemplary embodiment of a repair device that maybe utilized to perform a tricuspid repair procedure as described herein;

FIGS. 6-8 illustrate another embodiment of a repair device that may beutilized to perform a tricuspid repair procedure as described herein,showing deployment of extendable arms of the device and grasping ofleaflet tissue therebetween;

FIGS. 9 and 10 illustrate a superior view of a tricuspid valve showing arepair procedure using the repair device of FIGS. 6-8 to tie theleaflets of the tricuspid valve together to bring them closer together;

FIGS. 11 and 12 illustrate a side view of another exemplary embodimentof a clip device that may be utilized to perform a tricuspid repairprocedure, showing grasping of two adjacent leaflets of a tricuspidvalve using the device;

FIG. 13 illustrates a superior view of the clip device after graspingthe two adjacent leaflets;

FIGS. 14 to 16 illustrate side views of the clip device showing thedeployment of a suture line in a valve leaflet using a suturingcatheter;

FIG. 17 illustrates a superior view of the clip device after a pivotprocedure to grasp another leaflet of the tricuspid valve;

FIGS. 18 and 19 illustrate superior views of the clip device showing acinching procedure using the deployed suture line to tie adjacent valveleaflets to one another;

FIGS. 20 and 21 illustrate side views of the clip device showing analternative repair procedure which deploys a second suture line into asecond valve leaflet;

FIGS. 22 and 23 illustrate superior views of the clip device showing acinching procedure utilizing the two deployed suture lines to tieadjacent valve leaflets to one another; and

FIG. 24 illustrates closing of the clip device to bring the graspedvalve leaflets closer to one another.

DETAILED DESCRIPTION

At least some of the embodiments described herein are directed todevices and methods for repairing a malfunctioning cardiac valve, suchas a regurgitant tricuspid valve. Some embodiments are directed todevices and methods configured to provide repair of a regurgitanttricuspid valve through a “lasso” technique capable of tethering and/ortightening the three leaflets of the tricuspid valve together in adesired configuration to improve valve closure and minimize or eliminateregurgitation at the tricuspid valve.

Although many of the examples illustrated and described herein aredirected to tricuspid valve regurgitation, it will be understood thatthe principles, features, and components described herein may also beapplied in other applications, such as repair of other heart valves, oruse in other interventional procedures or treatment applications.

FIG. 1 illustrates a cross-sectional view of a heart 10 showing thenormal blood flow path. Deoxygenated blood enters the right atrium 16through the superior vena cava 14 and superior vena cava 12. Duringdiastole, suction from expansion of the right ventricle 20 andcontraction of the right atrium 16 forces blood from the right atrium 16across the tricuspid valve 18 and into the right ventricle 20. Duringventricular systole, blood is then forced from the right ventricle 20through the pulmonary valve 22 and into the pulmonary arteries fordelivery to the lungs. In a normally functioning heart, the tricuspidvalve 18 closes during systole to prevent backwards movement of bloodfrom the right ventricle 20 back into the right atrium 16. When atricuspid valve is not functioning properly, it may fail to fully closesuch that some of the blood passes back across the tricuspid valve 18and into the right atrium 16, rather than through the pulmonary valve22.

Oxygenated blood returning from the lungs enters the left atrium 24,where it is then passed through the mitral valve 26 and into the leftventricle 28. During ventricular systole, the blood is then passed fromthe left ventricle through the aortic valve for delivery throughout thebody. Similar to the right side of the heart, failure of the mitralvalve 26 to fully close during ventricular systole leads toregurgitation of blood from the left ventricle 28 back into the leftatrium 24. In some circumstances, problems related to mitral valveregurgitation or other issues with the left side of the heart also causeor are associated with structural issues on the right side of the heart,such as tricuspid valve regurgitation.

FIGS. 2-4 illustrate superior views of a tricuspid valve 18 in variousstates and positions. FIG. 2 illustrates a properly functioningtricuspid valve 18 in a closed position. A properly functioningtricuspid valve 18 takes this form during ventricular systole in orderto block backflow of blood. As shown, when in the closed position, thethree leaflets of the tricuspid valve 18 coapt to fully close the valve.FIG. 3 illustrates a properly functioning tricuspid valve 18 in an openposition. When open, the leaflets of the tricuspid valve 18 extenddownward into the right ventricle so that passage of blood through thetricuspid valve 18 is provided.

FIG. 4 illustrates a defective tricuspid valve 18 during ventricularsystole. In contrast to the properly closed tricuspid valve of FIG. 2,the leaflets of the defective tricuspid valve are unable to fully coapt,leaving a passage through which regurgitant blood may pass. Theinability to fully close may be due to defects to the leafletsthemselves, or to defects to other structures of the heart which deformthe tricuspid valve annulus or stretch the chordae tendineae, forexample.

FIG. 5 illustrates a cross-sectional view of an embodiment of a repairdevice 100 that may be utilized to reduce or eliminate regurgitation ina defective valve. The illustrated embodiment includes a proximal member102 and a distal member 104 disposed within the proximal member 102 andconfigured to be axially translatable relative to the proximal member102. Each of the distal member 104 and the proximal member 102 includearms extending transversely from respective longitudinal axes. In theillustrated embodiment, for example, the distal member 104 and proximalmember 102 are configured with T shaped cross sections. As indicated byarrows 106, the distal member 104 is translatable relative to theproximal member 102 such that the space between the arms of the distalmember 104 and the proximal member 102 may be selectively expanded orreduced.

As explained in more detail below, the repair device 100 may be utilizedto grasp tissue between the respective arms of the distal member 104 andproximal member 102 by positioning the distal member 104 on a first sideof the targeted tissue, with the proximal member 102 positioned on theopposite side of the targeted tissue, and translating the distal member104 relative to the proximal member 102 to reduce the space between thearms of the distal member 104 and proximal member 102 to grasp thetargeted tissue therebetween.

FIGS. 6-8 depict another embodiment of a repair device and an exemplarymethod for deploying a repair device to grasp tricuspid valve tissue forrepair of a regurgitant tricuspid valve. FIG. 6 illustrates a repairdevice including a distal member 204 positioned within a proximal member202 and extending out of and distally beyond a distal end of theproximal member 202. In the illustrated embodiment, the distal member204 is translatable relative to the proximal member 202 such that thedistal member 204 may be selectively extended distally or retrievedproximally relative to the proximal member 202.

In some embodiments, the repair device is delivered to the targetedtricuspid valve 18 by positioning the repair device in the right atrium,superior to the tricuspid valve 18, and extending the distal member 204through the tricuspid valve 18 into the right ventricle. For example,the repair device may be delivered via a transfemoral approach so thatthe device passes through the inferior vena cava into the right atrium.Alternatively, the device may be delivered through a transjugularapproach, transapical approach, or other approach.

Although the example depicted in FIGS. 6-8 is related to an approach inwhich the device is delivered to the right atrium and positionedsuperior to the tricuspid valve prior to deployment (e.g., through atransfemoral approach), it will be understood that the describedprinciples and features may be applied to other approaches. For example,in a transapical approach, the repair device may be inserted into theright ventricle and be positioned inferior to the tricuspid valve. Inthe illustrated example, the repair device is deployed by extending thedistal member 204 from the right atrium through the tricuspid valve 18and into the right ventricle. It will be understood that from aninferior approach, the repair device may be deployed by extending thedistal member 204 from the right ventricle through the tricuspid valveand into the right atrium.

As shown in FIG. 6, the proximal member 202 includes extendable arms 208and 210, and the distal member 204 includes extendable arms 212 and 214.FIG. 6 illustrates the arms 208, 210, 212, and 214 in a retracted orcollapsed position, providing the device with a low profile for deliveryto the targeted tricuspid valve 18. In the illustrated embodiment, theextendable arms 208, 210, 212, and 214 are coupled to the axial bodiesof the proximal member 202 and distal member 204, respectively, througha hinged attachment to enable actuation from the retracted position toan extended position. Alternatively, or additionally, one or more armsmay be provided with the ability to selectively extend and retractthrough use of spring biasing and/or tension wire controls (e.g., one ormore tension wires extending from a respective arm to a proximalhandle/control element).

In some embodiments, the distal member 204 and/or proximal member 202may be delivered in a sheathed configuration such that the correspondingarms, which are biased toward an expanded position, are held in acollapsed position by the sheath. The arms may then be selectivelyopened to the expanded position by retracting the corresponding sheathand/or pushing the respective member out from the sheath. The arms maybe retracted to a collapsed position by repositioning the correspondingsheath over the arms to force them back into the retracted position.

As shown in FIG. 6, the distal member 204 may be positioned so as topass through the plane of the tricuspid valve 18 and be positioned on aventricular side of the valve, while the proximal member 202 remains onthe atrial side of the valve. As shown in FIG. 7, the extendable arms208, 210, 212, and 214 may then be opened to the extended position sothat arms 208 and 210 of the proximal member 202 remain on the atrialside of the valve 18 and arms 212 and 214 remain on the ventricular sideof the valve 18. As shown in FIG. 8, the distal member 204 may then beproximally retracted and/or the proximal member 202 may then be distallyextended so as to bring the proximal (atrial side) arms 208 and 210closer to the distal (ventricular side) arms 212 and 214 so as to graspthe tricuspid valve tissue 18 therebetween, as indicated by the arrows216. In some embodiments, one or more of the arms 208, 210, 212, and 214may include tines, hooks, protrusions, or other structures to enhancetissue grasping.

As shown, the proximal arms 208 and 210 are each substantially alignedwith a corresponding distal side arm 212 and 214 to form an arm pair. Inthe illustrated embodiment, the proximal arm 208 and the distal arm 212form a first arm pair, and the proximal arm 210 and distal arm 214 forma second arm pair. Additional examples of repair devices are provided inU.S. Pat. No. 7,666,204, which is incorporated herein by reference inits entirety. One or more of the clip device components and/or featuresdescribed therein may be utilized for grasping tricuspid valve leaflettissue as part of a tricuspid valve repair procedure described herein.

FIGS. 9 and 10 illustrate superior views of the tricuspid valve 18showing deployment of any of the repair devices described herein inorder to affix the tricuspid valve leaflets so as to reduce or preventregurgitation through the tricuspid valve 18. Referring to FIG. 9, afirst leaflet and a second leaflet of the tricuspid valve 18 may begrasped according to the procedure illustrated by FIGS. 6-8 or throughanother grasping process. From the superior view of FIG. 9, the proximalarms 208 and 210 of the proximal member are shown extending across thefirst and second leaflets so that a first end of the proximal member islocated on the first leaflet at a first engagement point 216, and asecond end of the proximal member is located on the second leaflet at asecond engagement point 218 (i.e., so that the first arm pair is locatedat the first engagement point 216 and the second arm pair is located atthe second engagement point 218).

From this position, one or more suture lines are passed from the firstengagement point 216 to the second engagement point 218, or vice versa,to tie the first and second leaflets together. For example, one or moresuture lines may be tied or otherwise attached (e.g., using buttons,anchors, pledgets, etc.) at the first engagement point 216, and passedto the second engagement point 218 where they may be likewise attached.Alternatively, one or more suture lines may be anchored at or tied tothe second engagement point 218, but not passed to or from the firstengagement point 216.

In some embodiments, one or more suture loops are attached at the firstand/or second engagement points. For example, one or more suture linesmay be passed from the first engagement point 216 to the secondengagement point 218 where they are passed through a suture loopattached at the second engagement point 218. The one or more sutures maythen be further routed to other areas of the tricuspid valve 18, asdescribed in more detail below.

In alternative implementations, one or more suture lines may be anchoredto one of the engagement points but not passed between the first andsecond engagement points 216 and 218. For example, one or more suturinglines may be attached (e.g., using buttons, anchors, pledgets, or otheranchoring structures) at the second engagement point 218. The first andsecond leaflets are not sutured together, but the one or more suturelines anchored to the second leaflet at the second engagement point 218are subsequently passed to the third leaflet to tie the second leafletto the third leaflet. The one or more suture lines may be passed to thethird leaflet in this manner by a pivoting motion of the repair device,as shown in FIG. 10.

As shown in FIG. 10, the repair device is then pivoted so that thesecond arm pair is pivoted about a pivot point to position the secondend at the third leaflet. For example, as indicated by arrow 222 in theillustrated embodiment, the first engagement point 216 is used as apivot point, and the second arm pair is pivoted so that the second armpair is located on the third leaflet at a third engagement point 220. Insome embodiments, one or more suture lines may be passed from the secondengagement point 218 to the third engagement point 220 to tie the secondleaflet to the third leaflet. Additionally, in some implementations, oneor more suture lines may be passed from the third engagement point 220to the first engagement point 216 to tie the third leaflet to the firstleaflet.

In some embodiments, one or more suture lines are anchored at orthreaded through the leaflet tissue at through least two of the variousengagement points 216, 218, and 220 to form a suture lasso.Additionally, or alternatively, one or more suture lines are passedthrough one or more suture loops positioned at the engagement points216, 218, and/or 220. In some embodiments, one or more sutures are tiedto the first leaflet at the first engagement point 216 then passedthrough suture loop(s) at engagement point 218 (and in some embodimentspassed additionally through engagement point 220), or are tied/anchoredto the second leaflet at the second engagement point 218 then passedthrough suture loop(s) at engagement point 220. The one or more suturelines are then tightened to bring the leaflets of the tricuspid valve 18closer together to reduce or eliminate regurgitation through the valve.In some embodiments, one or more sutures are tied at the firstengagement point 216, then passed to both the second engagement point218 and third engagement point 220 before being passed back to the firstengagement point 216 to tie all three leaflets together.

The various engagement points 216, 218, and 220 may be positionedrelative to one another so as to provide a desired degree of tighteningand/or a desired amount of valve closure when the leaflets are cinchedcloser together with a suture lasso. Further, the suture lasso may betightened so as to provide a desired degree of closure to the leaflets.For example, in a procedure where a targeted tricuspid valve has arelatively greater degree of structural deformity, a suture lasso may betightened to a greater degree and/or one or more engagement points maybe positioned relatively further from the valve annulus and relativelycloser to a respective leaflet margin. In contrast, in a procedure wherea targeted tricuspid valve has a relatively lower amount of structuraldeformity, the suture lasso may be tightened to a lesser degree and/orone or more engagement points may be positioned relatively closer to thevalve annulus and further from a respective leaflet margin.

FIGS. 11 and 12 illustrate an exemplary embodiment of a repair deviceconfigured as a clip device 300, which may be utilized to grasptricuspid valve leaflet tissue and to aid in suturing at least twoadjacent leaflets to one another. The illustrated clip device 300includes a pair of proximal arms 308 and 310, and a corresponding pairof opposing distal arms 312 and 314. The arms 308, 310, 312, and 314 arepivotally connected to the shaft 324 so as to be adjustable between amore open configuration (as shown in FIG. 11 where the arms arerelatively more aligned to the axis of the shaft 324 and the device hasa lower profile) and a more closed position (as shown in FIG. 12 wherethe proximal and distal arms are brought toward one another to grasptissue therebetween). Proximal arms 308 and 310 can also include pointelements 328 that can engage or penetrate into the valve tissue whenproximal arms 308 and 310 are positioned against the tricuspid valve 18.

Typically, as shown in FIGS. 11 and 12, the clip device 300 ispositioned with distal arms 312 and 314 disposed on the distal side ofthe tricuspid valve 18 (e.g., the ventricular side when a transfemoralapproach is used) with the proximal arms 308 and 310 remaining on theproximal side of the valve (e.g., atrial side). The distal arms 312 and314 are then positioned against the leaflet tissue of the valve 18 andthe proximal arms 308 and 310 are then brought down to engage theleaflet tissue as shown in FIG. 12. After grasping, the arms 308, 310,312, and 314 can be adjusted to move the clip device 300 into a closedposition to bring grasped tissue closer together (see FIG. 24). The clipdevice may then be detached from the shaft 324 at detachment point 326and left within the heart valve as an implant.

The clip device 300 may include one or more control lines, actuatorrods, and/or other control mechanisms operably coupled to a handle toenable adjustments to the clip arms, detachment of the device, etc. Theclip device 300 is preferably delivered using a transfemoral approach,although a tranjugular approach, transapical approach, or other suitableapproach method may also be utilized.

The illustrated clip device 300 is also configured to enable suturing ofgrasped leaflet tissue. As shown, the distal arms 312 and 314 includethrough holes 330 and 332 for receiving suturing components. Theproximal arms 308 and 310 also include corresponding through holes 350and 352 (best seen in the superior view of FIG. 13). The correspondingthrough holes are formed so as to align when opposing arms are closedagainst tissue. As explained in more detail below, this allows suturingcomponents to pass through a proximal through hole, through leaflettissue, and into a distal through hole, in order to provide passageand/or positioning of one or more suture lines.

FIG. 13 illustrates a superior view of the clip device 300 that hasgrasped a first leaflet 41 and second leaflet 42 of the tricuspid valve18. From this view, the proximal arms 308 and 310 are visible, as wellas associated through holes 350 and 352 which provide passage throughthe proximal arms 308 and 310 to the underlying leaflet tissue. Afterleaflet tissue has been grasped in this manner, a suturing procedure canbe carried out using the repair device 300 to tie two or more of theleaflets together.

FIG. 14 illustrates, in side view, the same grasping position shown inFIG. 13. While the first and second leaflets 41 and 42 are grasped bythe clip device 300, a suturing catheter 402 is routed to the vicinityof the tricuspid valve. The suturing catheter 402 may be routed througha tranjugular approach or transfemoral approach (e.g., using the femuropposite from the one used for transfemoral delivery of the clip device300). The illustrated embodiments show a transjugular approach where thesuturing catheter 402 is positioned on the proximal side of the clipdevice 300 (e.g., on the atrial side) and passing one or more suturelines through leaflet tissue from the proximal side to the distal side,but it will be understood that the same components and principles ofoperation may be utilized by positioning the suturing catheter 402 onthe distal side of the clip device 300 and passing one or more suturelines through from the distal side to the proximal side.

As shown in FIG. 14, a first suture deployment catheter 404 is extendedfrom the suturing catheter 402, and is extended to the proximal arm 310.The first suture deployment catheter 404 is positioned through theproximal through hole 352, the second leaflet 42, and into thecorresponding distal through hole 332. A first suture line 408 (oroptionally two or more suture lines) is associated with the first suturedeployment catheter 404 so that as the first suture deployment catheter404 is passed from one side of the leaflet 42 to the other, the firstsuture line 408 is also passed through the leaflet 42. In someimplementations, a guide wire can first be passed out of the suturingcatheter 402, through the proximal through hole 352, through the leaflet42, and into the distal through hole 332 prior to moving the firstsuture deployment catheter 404, in order to establish a guided path forthe first suture deployment catheter 404.

In the illustrated embodiment, the first suture line 408 includes at adistal end a first suture anchor 412. The first suture anchor 412 can bea pledget, button, bight or bundle or suture, or other structure capableof holding position against the leaflet 42 to prevent movement ortearing through the leaflet 42 when tightening tension is applied to thefirst suture line 408. In some embodiment, the first suture anchor 412is flexible enough to bend and/or fold to a lower profile shape whenpassed through the leaflet 42, and is capable of expanding and/orfolding into a larger profile shape once passed to the distal side ofthe leaflet 42.

After deploying the first suture line 408, the first suture deploymentcatheter 404 is retracted, leaving the first suture line 408 deployed inthe leaflet 42, as shown in FIG. 15. From this position, the clip device300 can be selectively actuated to allow one end of the clip device 300to be moved to another leaflet, while the other end of the clip device300 remains anchored in place, thereby allowing another leaflet to besutured and tied to the already sutured leaflet 42.

As shown in FIG. 16, the proximal arm 310 is lifted from the leaflet 42.The first suture line 408 is still deployed/anchored to the leaflet 42and still passes through the proximal arm 310. The opposite proximal arm308 is held in a closed position against leaflet 41 so that the pointelement 328 of the proximal arm 308 can act as a pivot point for moving,via a pivoting motion, the clip device 300 from the previous position(in which the proximal arm 310 and distal arm 314 were positioned oneither side of leaflet 42) to a new position in which the proximal arm310 and distal arm 314 are positioned on either side of adjacent leaflet43. In some implementations, the distal arm 314 may be additionallymoved away from the leaflet 42. However, in a typical application,inherent fluctuations in leaflet position will allow the leaflet 42 tobe freed simply by lifting the proximal arm 310.

FIG. 17 illustrates a superior view of the tricuspid valve 18 showingthe clip device 300 after the pivoting motion. As shown, the proximalarm 308 remains grasped against the first leaflet 41, while proximal arm310 has been swung from the second leaflet 42 to the third leaflet 43.At this position, the proximal arm 310 and/or corresponding distal arm314 is/are adjusted to grasp the third leaflet 43. As shown, the firstsuture line 408 now extends from the second leaflet 42, where it isanchored at engagement point 318, to the third leaflet 43, where it isheld in place by the proximal arm 310. The free end of the first sutureline 408 passes up through the through hole 352 and into the suturingcatheter 402 (not shown in this view).

As shown in FIG. 18, the first suture line 408 can be tensioned (bypulling upward as indicated by arrow 336) to pull the second leaflet 42and third leaflet 43 toward one another to a desired degree, asindicated by arrows 334. As shown by FIG. 19, a lock 416 may then beapplied to maintain the length and/or tension of the first suture line408 between the engagement point 318 and the proximal through hole 352.

The lock 416 may be a cinch, clamp, grommet, stop, or other fasteningdevice capable of engaging against the suture line 408 to hold it inplace and prevent it from slipping past the lock 416. In someembodiments, the lock 416 may be applied using the suturing catheter402. In other embodiments, the lock 416 may form part of the clip device300 and may be selectively actuated to engage against the suture line408. In some embodiments, the suture line 408 may be slipped through abight or otherwise knotted, in addition to or as an alternative to thelock 416, in order to hold the position of the suture line 408. Excesssuture material may be cut from the device 300 prior to finishing therepair procedure.

After tensioning the first suture line 408 to tie the second leaflet 42and third leaflet 43 together, the clip device 300 may also be kept inthe position shown to tie the third leaflet 43 and first leaflet 41together. The clip device 300 may be adjusted toward a more closedposition, as shown in FIG. 24 and as indicated by arrows 344, toeffectively bring and hold together grasped tissue from the leaflets 43and 41.

FIGS. 20 through 23 illustrate an embodiment in which a second sutureline 410 is also deployed to tie targeted leaflet tissue together. FIG.20 shows a side view of the repair device 300 after it has been pivotedto the position shown in FIG. 17. In this position, the first sutureline 408 extends from the second leaflet 42 (not shown in this view) tothe proximal arm 310, where it passes up through the through hole 352and into the suturing catheter 402. As shown, a second suture deploymentcatheter 406 is extended from the suturing catheter 402. The secondsuture deployment catheter 406 deploys a second suture line 410 in amanner similar to that of the first suture deployment catheter 404 andfirst suture line 408, by passing through the through hole 352, throughthe third leaflet 43, and into the through hole 332. A second sutureanchor 414 functions to hold the second suture line 410 in a mannersimilar to that of the first suture anchor 412 holding the first sutureline 408.

As shown in FIG. 21, the second suture deployment catheter 406 is thenretracted, leaving the first and second suture lines 408 and 410 inposition extending through the proximal arm 310 and into the suturingcatheter 402. FIG. 22 shows a superior view of the repair device 300 inthis position. From this position, tension may be selectively applied tothe first and/or second suture lines 408, 410 to cinch and bring thesecond leaflet 42 and third leaflet 43 closer to one another. As shownin FIG. 23, a lock 416 may be deployed to maintain the positions of thefirst and second suture lines 408, 410. Excess suture material may becut from the device 300. As described above, the clip device 300 mayalso be kept in place across the third leaflet 43 and first leaflet 41,and may be moved to a closed position as shown in FIG. 24 to effectivelybring and hold together tissue from the grasped leaflets 43 and 41.

The combination of suturing a pair of adjacent leaflets and deployingthe clip device 300 across another pair of adjacent leafletsbeneficially provides effective repair of the tricuspid valve andeffective reduction or elimination of regurgitant flow through thevalve. In some embodiments, even further closing of a targeted tricuspidvalve is achieved by adding a suture to the first leaflet 41 (e.g., bypassing a suture deployment catheter through the proximal through hole350 of the proximal arm 308 in a manner similar to that described above)and connecting that suture to the engagement point 318 of the secondleaflet 42 to thereby stitch all three leaflets together.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount or condition close to the stated amount or conditionthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately,” “about,” and “substantially” mayrefer to an amount or condition that deviates by less than 10%, or byless than 5%, or by less than 1%, or by less than 0.1%, or by less than0.01% from a stated amount or condition.

Elements described in relation to any embodiment depicted and/ordescribed herein may be combinable with elements described in relationto any other embodiment depicted and/or described herein. For example,any element described in relation to a repair device of FIGS. 5 to 8 maybe combinable with any element described in relation to a clip device asillustrated by FIGS. 11 through 24.

The present invention may be embodied in other forms, without departingfrom its spirit or essential characteristics. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. A heart valve repair device, comprising: a pairof first arms; a pair of second arms disposed opposite the pair of firstarms, one first arm of the pair of first arms and one second arm of thepair of second arms forming a first arm pair, wherein the pair of firstarms and the pair of second arms are moveable between an openconfiguration in which the arms of the first arm pair are moved apartfrom one another and a closed configuration in which the arms of thefirst arm pair are brought toward one another to enable grasping ofleaflet tissue therebetween, wherein the first arm pair includes a pointelement configured to engage against leaflet tissue to function as apivot point about which a second arm pair pivots, the second arm pairincluding a set of through holes through which a line is passed toenable suturing of leaflet tissue grasped by the second arm pair; andwherein the second arm pair includes a lock configured to maintain alength or tension of the line.
 2. The repair device of claim 1, whereinthe second arm pair is configured to be adjustable independently fromthe first arm pair.
 3. The repair device of claim 1, wherein the linecomprises an anchor on an end of the line.
 4. The repair device of claim3, wherein each hole of the set of through holes is configured toaccommodate the anchor on the line.
 5. The repair device of claim 1,wherein each of the first arms is movable independently from the pair ofsecond arms.
 6. The repair device of claim 1, wherein one of the firstarms is configured to pivot toward one of the second arms.
 7. The repairdevice of claim 1, wherein one of the first arms is configured totranslate towards one of the second arms in a longitudinal direction. 8.The repair device of claim 1, wherein the lock is selected from a groupconsisting of a cinch, clamp, and grommet.
 9. The repair device of claim1, wherein the lock is configured to engage against the line to hold theline in place.
 10. A heart valve repair device, comprising: a pair ofdistal arms; a pair of corresponding proximal arms disposed opposite thepair of distal arms, each distal arm and corresponding opposite proximalarm forming an arm pair, wherein the pair of distal arms and the pair ofproximal arms are moveable between an open configuration in which thepair of distal arms and the pair of proximal arms are moved apart fromone another and a closed configuration in which the pair of distal armsand the pair of proximal arms are brought toward one another to enablegrasping of leaflet tissue therebetween, wherein one of the arm pairsincludes a point element configured to engage against leaflet tissue tofunction as a pivot point about which another arm pair rotates, theanother arm pair including a through hole through which a suture line ispassable to enable suturing of leaflet tissue grasped by the another armpair; and wherein the another arm pair includes a lock configured tomaintain a length or tension of the suture line.
 11. The repair deviceof claim 10, wherein the another arm pair is configured to be adjustableindependent of the arm pair.
 12. The repair device of claim 10, whereinthe suture line comprises an anchor on an end of the suture line. 13.The repair device of claim 10, wherein each arm of the pair of proximalarms is movable independently from each arm of the pair of distal arms.14. The repair device of claim 10, wherein one of the pair of proximalarms is configured to pivot toward one of the pair of distal arms. 15.The repair device of claim 10, wherein one of the pair of proximal armsis configured to translate towards one of the pair of distal arms in alongitudinal direction.
 16. The repair device of claim 10, wherein thelock is selected from a group consisting of a cinch, clamp, and grommet.17. The repair device of claim 10, wherein the lock is configured toengage against the suture line to hold the suture line in place.
 18. Aheart valve repair system, comprising: a clip device, the clip deviceincluding: two distal arms; two proximal arms disposed opposite the twodistal arms, one of the distal arms and one of the proximal arms forminga first arm pair and the other of the distal arms and the other of theproximal arms forming a second arm pair, wherein the distal arm andproximal arm of the first arm pair are moveable between an openconfiguration in which the distal arm and the proximal arm are movedapart from one another and a closed configuration in which the distalarm and the proximal arm of the first arm pair are brought toward oneanother to enable grasping of leaflet tissue therebetween, wherein atleast the first arm pair includes a point element configured to engageagainst leaflet tissue to function as a pivot point allowing the secondarm pair to rotate about the pivot point, the second arm pair includinga set of through holes through which one or more suture lines arepassable to enable suturing of leaflet tissue grasped by the second armpair; and wherein the second arm pair includes a lock configured tomaintain a length or tension of the one or more suture lines; and asuturing catheter having an internal lumen through which the one or moresuture lines are extendable, the suturing catheter being configured toengage with the second arm pair to enable passage of the one or moresuture lines through the leaflet tissue grasped by the second arm pair.19. The repair system of claim 18, wherein the suturing catheterincludes a suture deployment catheter which is extendable from thesuturing catheter.
 20. The repair system of claim 19, wherein the suturedeployment catheter is configured to pass into the set of through holesand to pierce the leaflet tissue grasped by the second arm pair todeploy the one or more suture lines.
 21. The repair system of claim 18,wherein each of the one or more suture lines include a distal anchormember which prevents the one or more suture lines from moving backthrough the leaflet tissue after being passed through the leaflettissue.
 22. The repair system of claim 21, wherein the distal anchormember comprises a pledget, button, or suture bight.
 23. The repairsystem of claim 18, wherein each of the proximal arms comprises athrough hole configured to accommodate the one or more suture lines. 24.The repair system of claim 23, wherein the point element comprises thethrough hole configured to accommodate the one or more suture lines. 25.The repair system of claim 18, wherein the lock is selected from a groupconsisting of a cinch, clamp, and grommet.
 26. The repair system ofclaim 18, wherein the lock is configured to engage against the one ormore suture lines to hold the one or more suture lines in place.